• Volunteers in clinical trials are protected by the FDA from exploitation.medicine image by Pali A from Fotolia.com
  
  Clinical trials are research studies in which human volunteers answer health questions and/or receive certain medical interventions. These studies are performed to investigate the effectiveness and toxicity of new therapeutics, evaluate new diagnostics, and explore options to improve quality of life for ill individuals. Often participating volunteers are compensated for their time. In other situations the institution performing the study must agree to compensate volunteers for any harm that results from the study. The Food and Drug Administration (FDA) sets regulations that deal with these methods of compensation.
  
  

Incentive vs. Coercion

• When volunteers are not participating in clinical trials in the hopes of potential health benefits, payment is often viewed as an incentive to recruit subjects. While volunteers may be compensated for their time and discomfort, they may not be coerced monetarily into participating. Payment must be proportional to time and discomfort. Exorbitant payment is considered coercion and is not allowed.
  
  

Payment for Future Issues

• When research involves more than minimal risk, volunteers must receive an explanation as to whether they will receive compensation should an injury occur. They must also be told what the form of compensation will be and if medical care will be available to them. Medical care should not be discontinued if the patient chooses to leave the study as this would be considered coercion to remain in the study.
  
  

Informed Consent

• Volunteers must sign a document explaining to them the nature of the research in which they will be participating. This is called an informed consent document and it must be explained to participants in a manner they can easily understand. This document must also clearly lay out all compensation that patients will receive, including monetary compensation and medical care.